MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Catalog Number	1011487-12
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the renal artery with mild calcification, mild tortuosity and 90% stenosis.The 4.0x12 mm herculink elite stent delivery system (sds) was flushed as normal and was advanced along the guide wire to the lesion.It was noted that the stent was dislodged on angiography as it was not on the delivery system.The stent dislodged inside the guiding catheter and when the guiding catheter was removed, the stent was removed without issue.Another same size herculink elite sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - device returning update from yes to no.
Event or Problem Description
It was reported that the procedure was to treat the renal artery with mild calcification, mild tortuosity and 90% stenosis.The 4.0x12 mm herculink elite stent delivery system (sds) was flushed as normal and was advanced along the guide wire to the lesion.It was noted that the stent was dislodged on angiography as it was not on the delivery system.The stent dislodged inside the guiding catheter and when the guiding catheter was removed, the stent was removed without issue.Another same size herculink elite sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to the initially filed report it was reported that the device was inflated and then it was noted the stent was not on the balloon.An additional herculink elite sds was received by the returned goods lab and the device was not used; however, the stent was found to be inside the sheath which was returned separately from the rest of the device.No additional information was provided.
Additional Manufacturer Narrative
Subsequent to filing the final report, it was determined that the herculink elite sds received by the returned goods lab which noted the device was not used, the stent was found to be inside the sheath, and was returned separately from the rest of the device is the complaint device for this complaint.Therefore, the following corrections have been made to the report: d9- device available for evaluation updated from ¿no¿ to ¿yes¿.H3 - device evaluated by mfg? updated from ¿no¿ to ¿yes¿.H6 - component code 4755 removed and code 515 added.Type of investigation code 4114 removed and code 10 added.H11 - additional mfg narrative: revised.The device was returned for analysis.The reported stent dislodgement was confirmed.The crimped condition the stent was returned in, indicates the stent was not expanded (activation failure).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18723092
• Report Number: 2024168-2024-01908
• Device Sequence Number: 17715191
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: (01)08717648077821(17)251031(10)2111061
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 1011487-12
• Device Lot Number: 2111061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 04/01/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/20/2024; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown